MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TRANSFER SHOWER BENCH WITH BACK AND PUSH BUTTONS; ADAPTOR, HYGIENE

Model Number G98013A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  Injury  

Event Description

The submitter is reporting the unit for posing a fall and injury hazard.He believes the units should be recalled.He states that he has almost fell in the shower while using the product.He said as he sits on the commode and shifts his weight to one side, getting ready to get up the bench snaps.He indicated that he has had 4-5 incidents but he has not fell or sustained injuries.He contacted the firm ((b)(6)) and reported the incident.He requested a replacement but the firm denied to provide one.The unit is used daily.The weight capacity is 250 lbs, and he said he weights (b)(6).(b)(4).Retailer: (b)(6).Purchase date: (b)(6) 2018 this date is an estimate.

• Brand Name: TRANSFER SHOWER BENCH WITH BACK AND PUSH BUTTONS
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9166808
• MDR Text Key: 161797402
• Report Number: MW5090267
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: G98013A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1